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Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults

Primary Purpose

Influenza, Human

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FLU Q-PAN H5N8 Formulation 1
AS03B
AS03A
FLU Q-PAN H5N8 Formulation 2
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza, Safety, Immunogenicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Medically stable participants as established by medical history and clinical examination before entering into the study. A male or female >=18 years of age at the time of signing consent form. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. Female participants of childbearing potential or non-childbearing potential may be enrolled in the study if specific criteria are met. Exclusion Criteria: Current diagnosis or history of autoimmune disorder(s) except hypothyroidism due to Hashimoto's thyroiditis. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Clinically significant acute or chronic pulmonary, cardiovascular, hepatic, or renal disease that appears uncontrolled or untreated, as determined by history or physical examination. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, physical examination, or abnormalities in screening blood tests. Recurrent history of or uncontrolled neurological disorders or seizures. History of Guillain-Barré syndrome. Diagnosed with cancer, or treatment for cancer within 3 years. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with a history of histologically confirmed basal cell carcinoma of the skin successfully treated with local excision only, are accepted and are eligible, but other histologic types of skin cancer are exclusionary. Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible. Documented human immunodeficiency virus-positive participants. Bedridden participants. Personal or family history of narcolepsy. Food and Drug Administration (FDA) toxicity Grade 2, or greater, laboratory tests at Screening. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the entire study period. Use of public health emergency vaccines like coronavirus disease 2019 (COVID-19), Monkey pox (mpox) etc. These can be given at any time, but there should a gap of 2 - weeks before a dose of study vaccine can be given. Use of any licensed vaccines: prior to receipt of the study vaccine and continuing up to 3 weeks after receiving the dose 2 of study vaccine. Administration of long-acting immune-modifying drugs at any time during the study period. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine or planned administration during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose and through the entire study period. For corticosteroids, this will mean prednisone equivalent >=20 milligrams/day for 14 days or a total of >=280 mg of prednisone equivalent dose in any 14-day period. Inhaled and topical steroids are allowed. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series. History of/or current drug/alcohol abuse. Any study personnel or their immediate dependents, family, or household member. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product.

Sites / Locations

  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

FLU Q-PAN H5N8 Formulation 1_B Group

FLU Q-PAN H5N8 Formulation 1_A Group

FLU Q-PAN H5N8 Formulation 2_B Group

FLU Q-PAN H5N8 Formulation 2_A Group

Arm Description

Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.

Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.

Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.

Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.

Outcomes

Primary Outcome Measures

Hemagglutination-inhibiting (HI) antibody titers against vaccine-homologous H5N8
HI antibody titers are expressed as GMTs.
Geometric mean fold rise (GMFR) of serum HI antibody titers against vaccine-homologous H5N8
GMFR is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
Percentage of seroprotected (SP) participants for HI antibody titers
SP is defined as the percentage of participants with HI antibody titer >=1:40.
Percentage of participants reporting each solicited administration site event
Solicited administration site events are pain, redness and swelling.
Percentage of participants reporting each solicited administration site event
Solicited administration site events are pain, redness and swelling.
Percentage of participants reporting each solicited systemic event
Solicited systemic events are fatigue, fever, headache, joint pain, shivering (chills) Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Percentage of participants reporting each solicited systemic event
Solicited systemic events are fatigue, fever, headache, joint pain, shivering (chills) Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Percentage of participants with increased toxicity grading in either Hematological or Biochemical Laboratory Parameters
The following laboratory assessments includes Hematology; complete blood count with differential and platelet count; Chemistry/metabolic panel: Sodium, Potassium, Creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase, total bilirubin, and blood urea nitrogen (BUN) which are graded by FDA toxicity grading scale. Assessed grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.
Percentage of participants with increased toxicity grading in either Hematological or Biochemical Laboratory Parameters
The following laboratory assessments includes Hematology; complete blood count with differential and platelet count; Chemistry/metabolic panel: Sodium, Potassium, Creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase, total bilirubin, and blood urea nitrogen (BUN) which are graded by FDA toxicity grading scale. Assessed grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.
Percentage of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event.
Percentage of participants reporting unsolicited AEs
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event.
Percentage of participants reporting medically attended adverse events (MAEs)
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).
Percentage of participants reporting MAEs
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).
Percentage of participants reporting serious adverse events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.
Percentage of participants reporting SAEs
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.
Percentage of participants reporting potential immune-mediated diseases (pIMDs)
pIMDs are a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Percentage of participants reporting potential immune-mediated diseases (pIMDs)
pIMDs are a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Secondary Outcome Measures

HI antibody titers against vaccine-homologous H5N8
HI antibody titers are expressed as GMTs. It is measured in terms of milliliter (mL).
GMFR of serum HI antibody titers against vaccine-homologous H5N8
GMFR is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
Percentage of seroprotected participants for HI antibody titers
SP is defined as the percentage of participants with HI antibody titer >=1:40.
Percentage of seroconverted participants for HI antibody titers
HI seroconversion is defined as a post vaccination titer >=1:40 in the serum of participants with pre-vaccination titer below 1:10 or as a >=4-fold rise in post vaccination HI titer with pre-vaccination titer >=1:10.
Microneutralization (MN) antibody titers for a subset of participants
MN antibody titers are expressed as Geometric Mean Titers (GMTs). MN analyses are performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).
Percentage of Seropositive participants for MN antibody titers for a subset of participants
A seropositive participant is a participant whose antibody titer is greater than or equal to the assay cut-off value. Note: The cut-off value for antibody titer is defined by the laboratory before the analysis. MN analyses is performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).
Percentage of participants meeting vaccine response (VR) criteria of MN antibody titers for a subset of participants
MN VR is defined as titer >=4*Lower limit of quantitation (LLOQ) for participants with pre vaccination titer below LLOQ or as a >=4-fold increase in MN titer for participants with pre vaccination titer >=LLOQ. MN analyses are being performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).
Percentage of seroprotected (SP) participants for HI antibody titers
SP is defined as the percentage of participants with HI antibody titer >=1:40.

Full Information

First Posted
July 27, 2023
Last Updated
October 3, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05975840
Brief Title
Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults
Official Title
A Phase I/II Observer-blind, Randomized, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System (Referred to as Q-Pan H5N8), Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
January 8, 2024 (Anticipated)
Study Completion Date
April 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults greater than or equal to (>=)18 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
Influenza, Safety, Immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This study will be observer blind.
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FLU Q-PAN H5N8 Formulation 1_B Group
Arm Type
Active Comparator
Arm Description
Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
Arm Title
FLU Q-PAN H5N8 Formulation 1_A Group
Arm Type
Active Comparator
Arm Description
Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 1 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
Arm Title
FLU Q-PAN H5N8 Formulation 2_B Group
Arm Type
Active Comparator
Arm Description
Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03B adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
Arm Title
FLU Q-PAN H5N8 Formulation 2_A Group
Arm Type
Active Comparator
Arm Description
Medically stable participants receive two doses of FLU Q-PAN H5N8 Formulation 2 vaccine and AS03A adjuvant. Participants receive the first dose at Day 1 and the second dose at Day 22.
Intervention Type
Biological
Intervention Name(s)
FLU Q-PAN H5N8 Formulation 1
Intervention Description
Participants receive two doses of the FLU Q-PAN H5N8 Formulation 1 vaccine by intramuscular injection in the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
AS03B
Intervention Description
Participants receive two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
AS03A
Intervention Description
Participants receive two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm.
Intervention Type
Biological
Intervention Name(s)
FLU Q-PAN H5N8 Formulation 2
Intervention Description
Participants receive two doses of the FLU Q-PAN H5N8 Formulation 2 vaccine by intramuscular injection in the non dominant arm.
Primary Outcome Measure Information:
Title
Hemagglutination-inhibiting (HI) antibody titers against vaccine-homologous H5N8
Description
HI antibody titers are expressed as GMTs.
Time Frame
At Day 43
Title
Geometric mean fold rise (GMFR) of serum HI antibody titers against vaccine-homologous H5N8
Description
GMFR is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
Time Frame
At Day 43
Title
Percentage of seroprotected (SP) participants for HI antibody titers
Description
SP is defined as the percentage of participants with HI antibody titer >=1:40.
Time Frame
At Day 43
Title
Percentage of participants reporting each solicited administration site event
Description
Solicited administration site events are pain, redness and swelling.
Time Frame
Within the 7-day follow-up period after first study intervention dose (administered at Day 1)
Title
Percentage of participants reporting each solicited administration site event
Description
Solicited administration site events are pain, redness and swelling.
Time Frame
Within the 7-day follow-up period after second study intervention dose (administered at Day 22)
Title
Percentage of participants reporting each solicited systemic event
Description
Solicited systemic events are fatigue, fever, headache, joint pain, shivering (chills) Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Time Frame
Within the 7-day follow-up period after first study intervention dose (administered at Day 1)
Title
Percentage of participants reporting each solicited systemic event
Description
Solicited systemic events are fatigue, fever, headache, joint pain, shivering (chills) Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Time Frame
Within the 7-day follow-up period after second study intervention dose (administered at Day 22)
Title
Percentage of participants with increased toxicity grading in either Hematological or Biochemical Laboratory Parameters
Description
The following laboratory assessments includes Hematology; complete blood count with differential and platelet count; Chemistry/metabolic panel: Sodium, Potassium, Creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase, total bilirubin, and blood urea nitrogen (BUN) which are graded by FDA toxicity grading scale. Assessed grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.
Time Frame
7 days after the first study intervention dose (administered at Day 1)
Title
Percentage of participants with increased toxicity grading in either Hematological or Biochemical Laboratory Parameters
Description
The following laboratory assessments includes Hematology; complete blood count with differential and platelet count; Chemistry/metabolic panel: Sodium, Potassium, Creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase, total bilirubin, and blood urea nitrogen (BUN) which are graded by FDA toxicity grading scale. Assessed grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, and Grade 4 = potentially life threatening.
Time Frame
7 days after the second study intervention dose (administered at Day 22)
Title
Percentage of participants reporting unsolicited adverse events (AEs)
Description
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event.
Time Frame
21 days after the first study intervention dose (administered at Day 1)
Title
Percentage of participants reporting unsolicited AEs
Description
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event.
Time Frame
21 days after the second study intervention dose (administered at Day 22)
Title
Percentage of participants reporting medically attended adverse events (MAEs)
Description
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).
Time Frame
21 days after the first study intervention dose (administered at Day 1)
Title
Percentage of participants reporting MAEs
Description
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).
Time Frame
21 days after the second study intervention dose (administered at Day 22)
Title
Percentage of participants reporting serious adverse events (SAEs)
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.
Time Frame
From Day 1 to Day 43
Title
Percentage of participants reporting SAEs
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.
Time Frame
From Day 1 to 6 months after the second study intervention dose (administered at Day 22)
Title
Percentage of participants reporting potential immune-mediated diseases (pIMDs)
Description
pIMDs are a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time Frame
From Day 1 to Day 43
Title
Percentage of participants reporting potential immune-mediated diseases (pIMDs)
Description
pIMDs are a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time Frame
From Day 1 to 6 months after the second study intervention dose (administered at Day 22)
Secondary Outcome Measure Information:
Title
HI antibody titers against vaccine-homologous H5N8
Description
HI antibody titers are expressed as GMTs. It is measured in terms of milliliter (mL).
Time Frame
Day 1, Day 22, and 6 months after the second intervention dose (administered at Day 22)
Title
GMFR of serum HI antibody titers against vaccine-homologous H5N8
Description
GMFR is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.
Time Frame
At Day 22 and 6 months after the second intervention dose (administered at Day 22)
Title
Percentage of seroprotected participants for HI antibody titers
Description
SP is defined as the percentage of participants with HI antibody titer >=1:40.
Time Frame
Day 1, Day 22, and 6 months after the second intervention dose (administered at Day 22)
Title
Percentage of seroconverted participants for HI antibody titers
Description
HI seroconversion is defined as a post vaccination titer >=1:40 in the serum of participants with pre-vaccination titer below 1:10 or as a >=4-fold rise in post vaccination HI titer with pre-vaccination titer >=1:10.
Time Frame
Day 22, Day 43, and 6 months after the second study intervention dose (administered at Day 22)
Title
Microneutralization (MN) antibody titers for a subset of participants
Description
MN antibody titers are expressed as Geometric Mean Titers (GMTs). MN analyses are performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).
Time Frame
Day 1, Day 22, 43, and 6 months after the second study intervention dose (administered at Day 22)
Title
Percentage of Seropositive participants for MN antibody titers for a subset of participants
Description
A seropositive participant is a participant whose antibody titer is greater than or equal to the assay cut-off value. Note: The cut-off value for antibody titer is defined by the laboratory before the analysis. MN analyses is performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).
Time Frame
Day 1, Day 22, Day 43, and 6 months after the second intervention dose (administered at Day 22)
Title
Percentage of participants meeting vaccine response (VR) criteria of MN antibody titers for a subset of participants
Description
MN VR is defined as titer >=4*Lower limit of quantitation (LLOQ) for participants with pre vaccination titer below LLOQ or as a >=4-fold increase in MN titer for participants with pre vaccination titer >=LLOQ. MN analyses are being performed on the MN subset that includes approximately 260 participants (50% of the planned enrolled participants).
Time Frame
Day 22, Day 43, and 6 months after the second study intervention dose (administered at Day 22)
Title
Percentage of seroprotected (SP) participants for HI antibody titers
Description
SP is defined as the percentage of participants with HI antibody titer >=1:40.
Time Frame
Day 1, Day 22, and 6 months after the second intervention dose (administered at Day 22)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Medically stable participants as established by medical history and clinical examination before entering into the study. A male or female >=18 years of age at the time of signing consent form. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. Female participants of childbearing potential or non-childbearing potential may be enrolled in the study if specific criteria are met. Exclusion Criteria: Current diagnosis or history of autoimmune disorder(s) except hypothyroidism due to Hashimoto's thyroiditis. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Clinically significant acute or chronic pulmonary, cardiovascular, hepatic, or renal disease that appears uncontrolled or untreated, as determined by history or physical examination. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, physical examination, or abnormalities in screening blood tests. Recurrent history of or uncontrolled neurological disorders or seizures. History of Guillain-Barré syndrome. Diagnosed with cancer, or treatment for cancer within 3 years. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. Persons with a history of histologically confirmed basal cell carcinoma of the skin successfully treated with local excision only, are accepted and are eligible, but other histologic types of skin cancer are exclusionary. Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible. Documented human immunodeficiency virus-positive participants. Bedridden participants. Personal or family history of narcolepsy. Food and Drug Administration (FDA) toxicity Grade 2, or greater, laboratory tests at Screening. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the entire study period. Use of public health emergency vaccines like coronavirus disease 2019 (COVID-19), Monkey pox (mpox) etc. These can be given at any time, but there should a gap of 2 - weeks before a dose of study vaccine can be given. Use of any licensed vaccines: prior to receipt of the study vaccine and continuing up to 3 weeks after receiving the dose 2 of study vaccine. Administration of long-acting immune-modifying drugs at any time during the study period. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine or planned administration during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose and through the entire study period. For corticosteroids, this will mean prednisone equivalent >=20 milligrams/day for 14 days or a total of >=280 mg of prednisone equivalent dose in any 14-day period. Inhaled and topical steroids are allowed. Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series. History of/or current drug/alcohol abuse. Any study personnel or their immediate dependents, family, or household member. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Facility Information:
Facility Name
GSK Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Almena L Free
Facility Name
GSK Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Harry Earl Studdard
Facility Name
GSK Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Corey Anderson
Facility Name
GSK Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Michael P Waters
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Kenneth T Kim
Facility Name
GSK Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Manuchehr Darani
Facility Name
GSK Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jaynier Moya
Facility Name
GSK Investigational Site
City
Chamblee
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Adebayo Akinsola
Facility Name
GSK Investigational Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Marian Shaw
Facility Name
GSK Investigational Site
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Crystal D Faudere
Facility Name
GSK Investigational Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Carlos A Fierro
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Mark Adams
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Scott P Striplin
Facility Name
GSK Investigational Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Charles A Thompson
Facility Name
GSK Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
William Smith
Facility Name
GSK Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Paul Pickrell
Facility Name
GSK Investigational Site
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Richard Lee Beasley
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jara McDonald
Facility Name
GSK Investigational Site
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Bonnie Colville
Facility Name
GSK Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Mary Bailey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
IPD Sharing URL
http://www.gsk.com/en-gb/innovation/trials/data-transparency

Learn more about this trial

Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults

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